Optimal Duration of Anticoagulation in Deep Venous Thrombosis
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
Prospective cohort study aimed at optimizing the duration of anticoagulant treatment in
patients at their first episode of proximal deep venous thrombosis (DVT) of the lower
extremities, whose pathogenesis is either unknown (idiopathic DVT) or associated with minimal
risk factors for thrombosis, with the help of an algorithm which incorporates both
ultrasonography and D-dimer information. All patients will be followed-up until 1) the
achievement of a major end-point; 2) the date of lost to to followup; 3) the date of death;
4) the date of study stop. The purpose of this study is to demonstrate the safety of
withholding anticoagulation from a subgroup of patients with proximal DVT whose veins have
recanalized and present with a repeatedly negative D-dimer (at baseline, after 1 and 3
months). The approach will be deemed to be safe if the annual rate of recurrent VTE in
patients who will have their anticoagulation discontinued is lower than 5%.
Phase:
Phase 3
Details
Lead Sponsor:
University of Padova
Treatments:
Anticoagulants Fibrin fragment D Vitamin K Warfarin